On 23 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Kisunla for the treatment of patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease in Great Britain. However, on the same day of its approval, the National Institute for Health and Care Excellence (NICE) announced that, initially, it would not be covering Kisunla for use in the UK’s National Health Service (NHS) on the grounds of an unfavourable risk-benefit profile and poor cost-effectiveness.
While disappointing for many patients with Alzheimer’s disease, the decision from NICE was not unexpected. This is the second time in 2024 that on the same day that MHRA approved a new disease-modifying therapy (DMT) for Alzheimer’s disease, the initial recommendation from NICE has been to not recommend the drug on the NHS. In August 2024, Eisai/Biogen’s anti-Aβ mAb Leqembi became the first DMT to be approved for MCI and mild Alzheimer’s disease in the UK, but it is also currently not recommended by NICE due to a lack of cost-effectiveness and concerns with safety.
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Kisunla’s approval was based on data from the Phase III TRAILBLAZER-ALZ 2 trial. Kisunla-treated patients demonstrated a slowed cognitive and functional decline of 35% compared with placebo-treated patients after 18 months, as measured by the primary endpoint, the Integrated Alzheimer’s Disease Rating Scale. In Leqembi’s pivotal Phase III trial (Clarity AD), it reduced clinical decline by 27% compared with placebo at 18 months, as measured by the primary endpoint, Clinical Dementia Rating-Sum of Boxes. While these DMTs are a major breakthrough in the Alzheimer’s disease market, the size of their effect is modest. As such, uncertainty remains among physicians and regulators as to whether this is a large enough reduction for patients to notice a real difference in their cognition to justify the cost of treatment. In the US, where both drugs are marketed, the annual cost of treatment is approximately $25,000 for Leqembi and $36,000 for Kisunla, according to GlobalData’s POLI pricing database. Furthermore, a known side effect of the anti-Aβ mAb drug class is the development of amyloid-related imaging abnormalities (ARIAs), including ARIAs related to underlying vasogenic oedema (ARIA-E). For Kisunla in TRAILBLAZER-ALZ 2, the rate of ARIA-E was 24.0% and the rate of symptomatic ARIA-E was 6.1%. Leqembi has the advantage, as the rate of ARIA-E in Clarity AD was 12.5% and the rate of symptomatic ARIA-E was 2.8%. To monitor the risk of ARIA, a magnetic resonance imaging (MRI) scan is required before treatment, and further MRIs are recommended prior to subsequent infusions, adding to the overall cost of therapy.
Importantly, NICE’s decisions for both drugs are not final. NICE had requested further evidence regarding the magnitude and benefit of the drugs’ effects and what the overall costs would be. This is particularly important to understand for Kisunla, as this drug is not designed to be taken indefinitely, so questions remain surrounding the average length of treatment with the drug and what happens once the treatment is stopped. However, it does mean that the total lifetime cost of therapy for Kisunla could be significantly cheaper than for Leqembi. A post-authorisation safety study has been planned by MHRA to evaluate the long-term effects of the drugs. Additional real-world experience, particularly from the US where both Leqembi and Kisunla have been approved and are prescribed, will also be crucial for the success of both drugs.
Leading data and analytics company GlobalData forecasts that in the eight major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, Japan, and China), Leqembi and Kisunla could generate sales of approximately $3.5bn and $2.0bn, respectively, in 2030.
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